Roche has provided an update to the community regarding the paused recruitment of RG6206, an investigational anti-myostatin adnectin, in ambulatory boys with Duchenne. The company hopes to restart recruitment in the second quarter of this year.
Read the update from Roche:
Dear Duchenne community members,
We would like to share an update of our phase 2/3 clinical study (study 227) with RG6206, our investigational anti-myostatin adnectin, in ambulatory boys with Duchenne (www.clinicaltrials.gov reference NCT030393686).
We recently detected an unexpected technical issue in the drug supply process, potentially impacting the availability of RG6206 for this ongoing study. Our priority is to ensure that boys in the study can continue study drug uninterrupted. To ensure we meet our commitments to new study participants, we have paused recruitment at all sites until we have resolved this situation.
Many of you have been waiting to join the study and we understand that this news may be disappointing. Please be assured that we are working to resolve this as quickly as possible and that we will restart recruitment as soon as we are confident that boys taking part in the study will have uninterrupted access to study drug.
It is important that those coming into the study can rely on us to deliver the investigational therapy they require for the duration of the study, so we are also putting in place measures to ensure that this technical issue will not happen again.
We expect that we will be able to reopen recruitment into study 227 in Q2 2018 and we will keep you updated on this.
Participants in the ongoing phase 1/2 clinical study (study 226) are not affected, all boys continue to receive study drug and the quality of study drug is not impacted.
Please visit www.clinicaltrials.gov and www.clinicaltrialsregister.eu for more information about the study. You can also read more about our Duchenne programme at www.roche-duchenne-clinicaltrials.com
Roche is committed to developing therapy that has the potential to improve the lives of those with Duchenne and we thank you for your support and understanding while we resolve this. If you have questions or would like to discuss, please reach out to me at firstname.lastname@example.org
Sangeeta Jethwa, MD, on behalf of the Roche Duchenne team
Head, Patient Partnership, Rare Disease, Roche, Switzerland